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Outcomes of Temporary Interruption of Rivaroxaban Compared With Warfarin in Patients With Nonvalvular Atrial Fibrillation: Results From ROCKET AF
Study Questions:
What are the reasons for temporary interruptions (TIs) of therapy during long-term anticoagulation in atrial fibrillation, the characteristics of patients undergoing TI, and the relationship between anticoagulant and outcomes among patients with TI?
Methods:
In the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial, a randomized, double-blind, double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation, baseline characteristics, management, and outcomes, including stroke, non-central nervous system systemic embolism (SE), death, myocardial infarction, and bleeding were reported in participants who experienced TI (3-30 days) for any reason. The at-risk period for outcomes associated with TI was from TI-start to 30 days after resumption of study drug. Association of randomized treatment with risk of outcome was assessed with Cox proportional hazards models in which each TI was an observation, and that used robust sandwich variance estimators to account for correlation of multiple TIs within participants.
Results:
In 14,236 participants who received at least one dose of study drug, 4,692 (33%) experienced TI. Participants with TI were similar to the overall ROCKET AF population in regards to baseline clinical characteristics. Only 6% (n = 483) of TI incidences involved bridging therapy. Stroke/SE rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants (0.30% vs. 0.41% per 30 days; hazard ratio [HR], 0.74; confidence interval [CI], 0.36-1.50; p = 0.40). Risk of major bleeding during the at-risk period was also similar in rivaroxaban-treated and warfarin-treated participants (0.99% vs. 0.79% per 30 days; HR, 1.26; CI, 0.80-2.00; p = 0.32).
Conclusions:
The authors concluded that TIs of oral anticoagulation are common and associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin.
Perspective:
In the ROCKET AF study, a large international population of participants with nonvalvular atrial fibrillation, temporary interruption of oral anticoagulation occurred in approximately 10% of patients/year, with only a minority of patients (<10%) receiving bridging therapy. During the at-risk period associated with TIs, the 30-day stroke/SE rate was 0.4% and major bleeding rate was 0.9%. The risks of thrombotic and bleeding complications were comparable between rivaroxaban- and warfarin-treated participants experiencing TI. Temporary interruption of oral anticoagulation should be avoided to minimize adverse outcomes, and additional research is necessary to determine the safest way to manage both warfarin and novel anticoagulant medications, such as rivaroxaban, during temporary interruptions.
Keywords: Vitamin K, Myocardial Infarction, Stroke, Proportional Hazards Models, Morpholines, Thiophenes, Warfarin, Atrial Fibrillation, Factor Xa, Embolism, Hemorrhage
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